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FDA Approves First Medical Device to Prevent Migraine Headaches

TENS headband stimulates trigeminal nerve

The FDA has allowed the marketing of Cefaly (STX-Med), the first device for the prevention of migraine. It is also the first transcutaneous electrical nerve stimulation (TENS) device approved for use before the onset of pain.

Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from 4 to 72 hours when left untreated. According to the National Institutes of Health, these debilitating headaches affect approximately 10% of people worldwide and are three times more common in women than in men.

Cefaly is a small, portable, battery-powered prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied.

Cefaly is indicated for patients 18 years of age and older and should be used only once per day for 20 minutes.

The FDA’s approval was based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headaches a month and who had not taken any medications to prevent migraines for 3 months prior to using Cefaly. Agency approval was also based on data from a patient-satisfaction study of 2,313 Cefaly users in France and Belgium who tested the device for 40 days.

The 67-person study, published online in Neurology in February 2013, showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine medication than did those who used a placebo device.

Between run-in and the third month of treatment, the mean number of migraine days decreased significantly in the patients using the Cephaly device (6.94 days vs. 4.88 days; P = 0.023), but not in the patients using a sham device (6.54 days vs. 6.22 days; P = 0.608). The 50% responder rate was significantly greater in the Cephaly group compared with the control group (38.1% vs. 12.1%, respectively; P = 0.023). Monthly migraine attacks (P = 0.044), monthly headache days (P = 0.041), and monthly acute intake of anti-migraine drugs (P = 0.007) were also significantly reduced in the Cephaly group but not in the control group.

In this study, however, the Cefaly device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient-satisfaction study, published in the Journal of Headache and Pain in December 2013, showed that more than half of the patients (54.4%) were satisfied with Cefaly treatment and were willing to buy the device for continued use.

In this study, the most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

No serious adverse events occurred during either study.

Sources: FDA; March 11, 2014; Neurology; February 19, 2013; and JHP; December 1, 2013.

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